What if the study submitted is not adequate (not a good study)?
A21. If the study submitted with an application is not adequate, the sponsor will not have satisfied the pediatric study requirements. Further study would be necessary unless the requirement is waived. Presumably, if the adult indications were ready for approval, the Division could approve the application for adults with a deferral of the pediatric data until a specified time for completion of the pediatric requirement. Please note that an inadequate study that meets the terms of a Written Request (FDAMA) may still earn pediatric exclusivity, even if the study is not adequate for approval.
